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Quality Systems Manager

Quality Systems Manager – Medical Devices/Wound Care/Pharmaceuticals
Significant career opportunity for a quality systems professional
Support all aspects of their QMS for this leading-edge global player

Full time
Highly attractive lifestyle area Skipton/Gargrave, North Yorkshire
Market competitive salary plus broad ranging benefits

Systagenix, part of a leading international group, provides innovative products and services to drive breakthrough clinical and economic outcomes in the management and healing of chronic and acute surgical wounds, offering a wide range of wound care products to meet the needs of healthcare professionals and patients. Systagenix’s longstanding commitment to skin and wound care began with innovative wound care products developed by the experienced team of R&D Scientists at their Gargrave Centre of Excellence for Wound Healing in North Yorkshire.

Reporting to the Senior Quality Director Global Operations as Quality Systems Manager, you’ll provide quality management support to all aspects of the quality system at this large manufacturing facility. Managing and maintaining the Quality Management System to ensure compliance to all regulations, including risk management files in accordance with ISO 14971, you’ll also manage and co-ordinate CAPA activities on-site, feeding into the corporate CAPA system and internal audit and training programmes. As an influential team member of the site management team, you’ll independently review non-conforming material reports, deviations and change orders whilst driving changes in procedures and standards to facilitate efficiency and maintain quality. In addition to supporting regulatory submissions requirements and maintaining/updating site metrics on the QMS, you’ll also:

- consistently promote awareness of industry best practice
- take a leadership role in developing and implementing new techniques to enhance the QMS, both on-site and across the corporation
- develop staff on new quality initiatives and their rollout

With a degree in Quality, Engineering, Science or another related subject, you must have substantial experience in a medical devices, pharmaceutical or food industry regulated environment, together with thorough knowledge and understanding of FDA, ISO 13485 and other regulatory, country-specific standards.
Your organised, methodical approach, with strong, all-round communication skills, complements your pro-active approach and ability to plan and prioritise, whilst meeting tight deadlines, in addition to:

- flexibility around core hours to ensure that high standards are met
- the ability to forge string working partnership with key stakeholders and internal client group

The career prospects are excellent in this international group and the salary and benefits package is comprehensive. You will be expected to live within a reasonable commute of this highly attractive lifestyle area Skipton/Gargrave North Yorkshire.

Please forward in absolute confidence a full curriculum vitae, to Adderley Featherstone by clicking on the apply button and completing a short application.

Your application will be treated with absolute confidentiality.
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